Farouk 2016.
Study characteristics | ||
Methods | Randomised controlled trial Setting: Ain‐Shams University Maternity Hospital, Egypt |
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Participants | 24 women with primary PPH (blood loss more than 1000 mL) within 2 hours of birth and not responding to first‐line treatment. The majority of women (more than 70% in both groups) had primary atonic PPH, the remainder of the women had PPH due to lacerations or bleeding at the placental site. Exclusion criteria: "history of coagulopathy, thrombocytopenia or anticoagulant therapy, HELLP syndrome or eclampsia, impaired serum creatinine, and mental conditions rendering the patient unable to understand the nature, scope and possible consequences of the study" p 818 |
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Interventions |
Intervention: uterine arterial embolisation (11 women ‐ 1 other women refused to have UAE). Of the 11 randomised, 9 had vaginal delivery and 2 had caesarean section. "The procedures were done under fluoroscopic control using monoplane cath‐laboratory unit (Toshiba‐Japan) with a 5Fsheath (TERUMO) and a 5F Cobra2 catheter (Cordis) with a 0.35F hydrophilic guide wire (TERUMO). The sheaths were left in place for 24 hours and the patients were transferred to the ICU." p 818 Control: "emergency laparotomy for stepwise devascularisation and compression sutures" p 818 (12 women). Of the 12 women, 8 had vaginal delivery and 4 had caesarean section. |
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Outcomes |
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Notes |
Trial authors' declarations of interest: "we have no conflicts of interest to declare" p 823 Sources of trial funding: not mentioned Trial dates: May 2011 until May 2013 Informed consent obtained?: "Approval was obtained from the ethical committee of the department of Obstetrics and Gynecology, Ain‐Shams University" p 818 Ethics approval obtained?: yes ‐ "oral consent was obtained from each participant before proceeding to either of the options" p818 Did we attempt to contact the trial authors?: no |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The patients were randomized using a computer‐generated list (MedCalc version 13.2.2, Acacialaan 22, Ostend, Belgium) in a 1:1 ratio into 2 groups" (p 818) |
Allocation concealment (selection bias) | Unclear risk | "The randomization protocol was also concealed using closed envelopes so that each envelope contained the name of one of the 2 options" (p 818) Comment: does not state whether envelopes were opaque or consecutively numbered |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned. Assume blinding of personnel not possible due to difference in intervention techniques between groups |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 women in the intervention group refused to give consent. All other women were accounted for |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |
Other bias | Low risk | No other sources of bias were apparent |